WO2016193513A1 - Dispositivo de recolección de sangre - Google Patents

Dispositivo de recolección de sangre Download PDF

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Publication number
WO2016193513A1
WO2016193513A1 PCT/ES2016/070388 ES2016070388W WO2016193513A1 WO 2016193513 A1 WO2016193513 A1 WO 2016193513A1 ES 2016070388 W ES2016070388 W ES 2016070388W WO 2016193513 A1 WO2016193513 A1 WO 2016193513A1
Authority
WO
WIPO (PCT)
Prior art keywords
piston assembly
tube
assembly
end portion
handle assembly
Prior art date
Application number
PCT/ES2016/070388
Other languages
English (en)
Spanish (es)
French (fr)
Inventor
Eduardo Anitua Aldecoa
Original Assignee
Biotechnology Institute, I Mas D, S.L.,
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to KR1020177034501A priority Critical patent/KR20180014711A/ko
Priority to CN201680031851.XA priority patent/CN107735028B/zh
Priority to BR112017025837-4A priority patent/BR112017025837B1/pt
Priority to ES16726353T priority patent/ES2751678T3/es
Priority to EP16726353.2A priority patent/EP3305195B1/en
Priority to JP2017562709A priority patent/JP6737817B2/ja
Application filed by Biotechnology Institute, I Mas D, S.L., filed Critical Biotechnology Institute, I Mas D, S.L.,
Priority to RU2017141930A priority patent/RU2694468C2/ru
Priority to PL16726353T priority patent/PL3305195T3/pl
Priority to MX2017013467A priority patent/MX361558B/es
Priority to CA2988027A priority patent/CA2988027C/en
Publication of WO2016193513A1 publication Critical patent/WO2016193513A1/es
Priority to CONC2017/0013373A priority patent/CO2017013373A2/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150015Source of blood
    • A61B5/15003Source of blood for venous or arterial blood
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150053Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
    • A61B5/150061Means for enhancing collection
    • A61B5/150099Means for enhancing collection by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150206Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150236Pistons, i.e. cylindrical bodies that sit inside the syringe barrel, typically with an air tight seal, and slide in the barrel to create a vacuum or to expel blood
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150206Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150244Rods for actuating or driving the piston, i.e. the cylindrical body that sits inside the syringe barrel, typically with an air tight seal, and slides in the barrel to create a vacuum or to expel blood
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150206Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150259Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150351Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150572Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150755Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150885Preventing re-use
    • A61B5/150908Preventing re-use by disconnecting components, e.g. breaking or rupturing of connected parts, e.g. piston and rod
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/153Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/153Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
    • A61B5/154Devices using pre-evacuated means
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/508Containers for the purpose of retaining a material to be analysed, e.g. test tubes rigid containers not provided for above
    • B01L3/5082Test tubes per se
    • B01L3/50825Closing or opening means, corks, bungs
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00Sampling; Preparing specimens for investigation
    • G01N1/02Devices for withdrawing samples
    • G01N1/10Devices for withdrawing samples in the liquid or fluent state
    • G01N1/14Suction devices, e.g. pumps; Ejector devices
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/06Fluid handling related problems
    • B01L2200/0689Sealing
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/14Process control and prevention of errors
    • B01L2200/141Preventing contamination, tampering
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/04Closures and closing means
    • B01L2300/041Connecting closures to device or container
    • B01L2300/045Connecting closures to device or container whereby the whole cover is slidable

Definitions

  • the invention relates to a device for collecting blood or a blood compound as a result of suction or vacuum, and in particular a device having a tube, a piston and a detachable handle to generate the vacuum in the tube moments before use the device, guaranteeing optimal vacuum conditions at the time the device is used for example to collect blood taken from a patient.
  • sealed and vacuum closed tubes are generally used, that is, with a pressure of the inner atmosphere less than the pressure at which the blood is in the veins.
  • the tubes are closed by a plug or pierceable closure, such as a septum.
  • the blood is drawn by inserting a hypodermic needle into the vein or artery of the person or animal, said needle being connected to an opposite needle, which in turn pierces the pierceable tube closure and is inserted into the tube vacuum closed.
  • a blood draw occurs due to pressure differences from the vein or artery to the tube, which ends when the needle is removed from the body.
  • the vacuum tubes used to draw blood have a simple configuration, in the form of an elongated receptacle closed at one end by said perforable closure, and which is provided with vacuum at the factory, that is, during its manufacture.
  • Normally, health centers or agencies are supplied with a large number of tubes that are stored and used only when it is necessary.
  • the capacity of the receptacles and perforable closures to maintain the vacuum created at the factory is limited, since the tubes lose their optimum vacuum conditions over time through the joints between parts and even through the walls of the tube.
  • the tubes can be manufactured with greater thicknesses and / or with components that provide a more tight seal, which results in an increase in the manufacturing cost of the tubes.
  • the purpose of the present invention is to provide a blood collection tube that is capable of presenting optimal vacuum conditions at the time of use, and at the same time presenting a reasonable cost so as to constitute a viable alternative to the tubes. Vacuum used today.
  • the present invention has as its object a device for collecting blood or a blood compound, which can be manipulated at the time of its use to create conditions of depression or emptiness inside, and that once created the vacuum can present a final shape analogous to a conventional tube so that it can be used in standard or conventional medical systems and equipment such as centrifugal machines, support racks and pipetting, etc. without requiring specific accessories to be used.
  • the device has a very effective and at the same time simple configuration, which allows the construction of a disposable tube at a reasonable cost.
  • the device according to the invention comprises a tube, a pulling assembly, a piston assembly and a pierceable sealing element.
  • the tube is it extends along a longitudinal axis and has a side wall, a closed distal end, a proximal end opposite the distal end and an inner cavity communicated with the outside by an opening in said proximal end.
  • the piston assembly is movable along the inner cavity of the tube, in tight contact with the side wall of the tube, and has at least one inner clipping surface and a longitudinal inner cavity.
  • the piston assembly delimits a space between said piston assembly and the distal end of the tube.
  • the handle assembly in turn, has a gripping portion, a separable zone (for example breakable, disengaging or with a disconnectable clipping) and an end portion extending from said separable zone.
  • the extreme portion has a longitudinal interior cavity and at least one clipping surface.
  • the end portion of the handle assembly is movable with respect to the piston assembly to a position where at least one clipping surface of the end portion contacts an inner clipping surface of the piston assembly preventing removal of the end portion of the piston assembly.
  • the pierceable sealing element prevents the passage of fluid from the delimited space between said piston assembly and the distal end of the tube and into the longitudinal interior cavity of the end portion of the handle assembly.
  • the grip portion of the handle assembly is accessible from the outside of the device.
  • the user can therefore, in said clipping position, push back the assembly formed by the handle assembly, the piston assembly and the pierceable sealing element to a position closer to the proximal end of the tube, creating a depression in the tube caused by the recoil of the piston assembly and the consequent increase in volume of the space between the piston assembly and the distal end of the tube. Then, the user can separate and remove an important part of the handle assembly, obtaining a vacuum closed tube with a tight seal and pierceable by a needle.
  • the container of the present invention allows the vacuum to be generated just before being used, it is possible to have optimum vacuum conditions at the time of using the container without therefore the container having to be manufactured with expensive materials or stored under conditions strict temperature.
  • the device of the present invention is also advantageous in that it only has one open end provided with closure pieces (the proximal end of the tube), which allows greater centrifugal pressures when the centrifugal force acts against the distal and hemispherical end of the tube , which has no continuity solution.
  • FIG. 1 shows a perspective view of an example of a blood collection device or a blood compound according to the invention.
  • FIG. 2 shows an exploded view of the device of Figure 1, showing the tube, the handle assembly, the pierceable sealing element, the piston assembly and the cover.
  • FIG. 3 shows a sectional view of the end of the handle assembly of Figure 2 in which the end portion and the separable zone are located.
  • Figure 4 shows a sectional view of the pierceable sealing element of Figure 2.
  • FIG. 5 shows a sectional view of the lid of Figure 2.
  • Figure 6 shows a sectional view of the piston assembly of Figure 2.
  • Figure 7 shows a sectional view of the device of Figure 1 in a first pre-assembly situation.
  • FIG. 8 shows a sectional view of the device of the Figure 1 in a second situation, in which the handle assembly, the sealing element and the piston assembly have been introduced into the tube and the cover fixed to the tube.
  • Figure 9 shows a sectional view of the device of Figure 1 in a third situation, in which the pull assembly, piston assembly and pierceable sealing element has been pushed to the bottom of the tube.
  • Figure 10 shows an enlarged view of the piston assembly, the pierceable sealing element and the end portion of the handle assembly in the situation of Figure 9.
  • Figure 1 1 shows a sectional view of the device of Figure 1 in a fourth situation, in which the handle assembly has been pushed, causing the handle assembly to be clipped to the piston assembly and that the pierceable sealing element remains in its final position ensuring sealing.
  • Figure 12 shows an enlarged view of the piston assembly, the pierceable sealing element and the end portion of the handle assembly in the situation of Figure 1 1.
  • Figure 13 shows a sectional view of the device of the
  • Figure 1 in a fifth situation, in which the pulling assembly has been pulled back, causing the recoil of the pulling assembly, piston assembly and perforable sealing element, generating a depression inside the tube.
  • Figure 14 shows an enlarged view of the piston assembly, the pierceable sealing element, the end portion of the handle assembly and the cover in the situation of Figure 13.
  • Figure 15 shows a sectional view of the device of the
  • Figure 16 shows an enlarged view of the piston assembly, the pierceable sealing element, the end portion of the handle assembly and the cover of Figure 15.
  • Figure 17 shows a sectional view of the device of Figure 1 in a sixth situation, in which the handle assembly has been pulled back and the handle assembly turned clockwise, causing the piston assembly to remain clipped to the lid.
  • Figure 18 shows an enlarged view of the piston assembly, the pierceable sealing element, the end portion of the handle assembly and the cover in the situation of Figure 17.
  • Figure 19 shows a sectional view of the device of Figure 1 in a seventh situation, in which the handle assembly has been broken in the separable zone, and the entire handle assembly removed except the end portion, leaving a vacuum container and pierceable for use to collect blood for suction, or for another application.
  • Figure 20 shows an enlarged view of the piston assembly, the pierceable sealing element, the end portion of the handle assembly and the cover in the situation of Figure 19.
  • Figure 21 shows a sectional view of a second embodiment of the device according to the invention in which the handle assembly has a detachable clipped area, said device having been represented in a situation analogous to the situation of Figure 17, that is, in which the handle assembly has been pulled back and the handle assembly has been turned clockwise, causing the piston assembly to be clipped to the lid.
  • Figure 22 shows an enlarged view of the piston assembly, the pierceable sealing element, the separable zone and end portion of the handle assembly, and the cover in the situation of Figure 21.
  • Figure 23 shows a sectional view of the device of Figure 21, in a later situation in which most of the handle assembly has been unclipped and removed, leaving a vacuum and perforable container for use to collect blood by effect of suction, or for another application.
  • Figure 24 shows an enlarged view of the piston assembly, the pierceable sealing element, the separable zone and end portion of the handle assembly, and the cover in the situation of Figure 23.
  • Figure 25 shows an enlarged view of a third embodiment of the device according to the invention, in a situation in which the end portion of the handle assembly has not yet been clipped to the piston assembly.
  • FIG. 26 shows the device of Figure 25, in a later situation in which the end portion of the handle assembly has been clipped to the piston assembly.
  • FIG. 27 shows an enlarged view of a fourth embodiment of the device according to the invention, in a situation in which the end portion of the handle assembly has not yet been clipped to the piston assembly.
  • FIG. 28 shows the device of Figure 27, in a later situation in which the end portion of the handle assembly has been clipped to the piston assembly.
  • FIG. 29 shows an enlarged view of a fifth embodiment of the device according to the invention, in a situation in which the pulling assembly has not yet been clipped to the piston assembly.
  • FIG. 30 shows the device of Figure 29, in a later situation in which the end portion of the handle assembly has been clipped to the piston assembly.
  • the invention relates to a device for collecting blood or a blood compound as a result of suction or vacuum, and in particular a device having a tube, a piston assembly and a detachable pull assembly for generating the vacuum in the tube instants before using the device, guaranteeing optimum vacuum conditions at the time the device is used for example to collect blood taken from a patient.
  • Figures 1 to 20 show an exemplary embodiment of said device.
  • Figure 1 shows an external perspective of the device (1), in assembled state.
  • Figure 2 shows an exploded perspective of the device (1), allowing to illustrate the different components thereof.
  • the device (1) of the present embodiment comprises a tube (10), a pulling assembly (30), a piston assembly (50), a pierceable sealing element (70) and a cover (90 ).
  • the tube (10) extends along a longitudinal axis (1 1) and has a side wall (12), a distal end (13), a proximal end (14) opposite the distal end (13) and a cavity interior (15), not visible in the present figure.
  • Figure 7 shows the tube (10) in section, the inner cavity (15) being visible, which is communicated with the outside of the tube (10) by an opening (16) located in said proximal end (14).
  • the distal end (13) of the tube is a closed end.
  • the tube (10) is made entirely in one piece and material, for example of glass, or injected plastic, so that the walls of the distal end (13) are a continuation of the side wall (12).
  • the handle assembly (30) has an elongated body (31) and a grip portion (32) or handle, which in the embodiment shown is at one end of the elongated body (31 ) and forms a T with the elongated body (31).
  • the handle assembly (30) further comprises a separable zone (33) and an end portion (34) extending from said separable zone (33) and in the opposite direction to the grip portion (32) (i.e. at one end of the elongated body (31) opposite the end where the grip portion (32) is located.
  • the end portion (34) has a longitudinal interior cavity (35).
  • Figure 3 shows an enlarged view of the end of the handle assembly (30), the arrangement of the separable zone (33) made in the form of a notch or narrowing between the elongated body (31) and the end portion (34) being more clearly seen. ).
  • the separable zone (33) is breakable, that is, it is possible to separate the grip portion (32) of the handle assembly (30) from the end portion (34) of the handle assembly (30) by breaking said separable zone (33) of the handle assembly (30).
  • the end portion (34) of the handle assembly (30) has at least one clipping surface (36), intended to be clipped to the piston assembly (50) as will be explained below, and at least one surface side (37) oblique and of increasing width towards the clipping surface (36), which contributes to causing the clipping.
  • the lateral surface (37) can be conical, curved or a combination of both.
  • the main body (51) comprises a through cavity (53), also longitudinal; said inner cavity (53) is delimited by an inner wall (54).
  • the main body (51) further comprises at least one inner clipping surface (55) arranged radially or transversely.
  • the piston assembly comprises in particular two inner clipping surfaces (55). More specifically, the main body (51) comprises an annular outer surface (56), arranged around the inner cavity (53) and oriented towards the handle assembly (30), from which two elastic pins (57) extend.
  • the elastic pins (57) are provided with a transversely flexible trunk (58) and a head (59), said trunk (58) and said head (59) forming an approximate shape of T.
  • the head (59) has a part upper (60) oblique, which can be conical, curved or a combination of both, and which in the present embodiment is substantially hemispherical; in its lower zone, the head (59) has a transverse lower part on each side of the trunk (58), one of said transverse lower parts being the inner clipping surface (55) and the other of said transverse lower parts being a surface outer clipping (61).
  • a space (15a) is defined between the piston assembly (50) and the distal end (13) of the tube (10).
  • the piston assembly (50) is movable along the inner cavity (15) of the tube (10) and in tight contact with the side wall (12) of the tube (10), so that when the piston assembly is sealed tightly ( 50) along the inner cavity (15) and towards the proximal end (14) there is a depression in the space (15a) delimited between the piston assembly (50) and the distal end (13) of the tube (10) .
  • the piston assembly (50) of the present embodiment it comprises an elastic skirt (62), more clearly visible in Figure 6.
  • Said skirt (62) extends backwards from a joining area (64) in an end portion of the main body (51), and is elastic so that it can be folded laterally inwards and outwards with respect to said joint zone (64), which functions as a hinge.
  • the skirt (62) tends to open elastically in the radial direction, as will be seen later, it can thus be adjusted tightly against the side wall (12) of the tube (10).
  • the pierceable sealing element (70), visible in Figure 2 and in greater detail in Figure 4, has a disc-shaped head (71), and a trunk (72) narrower than the head (71) and extending from said head (71) in the longitudinal direction.
  • An inner cavity (73) is disposed in the trunk (72), practically in its entire length; In the embodiment shown, for example, the inner cavity (73) is arranged along more than three quarters of the length of the trunk (72).
  • Figure 5 in turn, consists of a transverse wall (91) and a lateral wall (92), between which an interior space (93) is delimited.
  • the side wall (92) has an inner surface (94) and an outer surface (95).
  • the interior space (93) and the interior surface (94) are adapted in size and shape to receive the proximal end (14) of the tube (10); for example, in the present embodiment, the inner surface (94) is cylindrical and has a diameter only slightly larger than the outer diameter of the tube (10) to allow a smooth but tight placement of the cap (90) on the tube (10)
  • the transverse wall (91) there is a hole (96) that is connected to the interior space (93).
  • the hole (96) is generally cylindrical, and comprises at least one radial recess (97) that provides a transverse seat surface or clipping surface (98). Said radial inlet (97) is communicated with the space inside (93) by a helical channel (99).
  • Figures 7 to 20 show a sequence of use of the device (1) according to the invention, along which the different components of the device (1) are assembled and in which vacuum conditions are created inside the device ( one ).
  • Figure 7 illustrates a first step, in which the cover (90) is placed in the handle assembly (30) by inserting the end portion (34) and the elongated body (31) of the handle assembly (30) through the hole (96 ) and the interior space (93) of the cover (90).
  • the pierceable sealing element (70) is coupled to the end portion (34) of the handle assembly (30), specifically inserting the trunk (72) and part of the head (71) of the pierceable sealing element (70) into the longitudinal interior cavity (35) of said end portion (34).
  • the piston assembly (50) is disposed near the end portion (34) and the pierceable sealing element (70).
  • the end portion (34) of the handle assembly (30), the pierceable sealing element (70) and the piston assembly (50) are inserted into the inner cavity (15) of the tube (10), through the opening (16), and the cover (90) is fixed to the tube (10).
  • the tube (10) has an outer thread (17), visible in Figures 2 and 7, to which a corresponding thread is screwed into the inner surface (94) of the wall side (92) of the cover (90) (said corresponding thread not being shown in the figures).
  • Said increase in pressure causes the pressure in front of the piston assembly (50) to be greater than behind the piston assembly (50), which results in a resulting force on the skirt (62) of the piston assembly (50) towards inside, as indicated schematically with the arrow (B). Consequently, the skirt (62) folds slightly inwards with respect to the junction zone (64), and gaps are formed between the skirt (62) and the side wall (12) of the tube (10), allowing passage of air from space (15a) through said gaps and therefore the piston assembly (50) can move forward.
  • FIG. 1 shows an enlarged view of the piston assembly (50) in this situation.
  • the longitudinal thrust of the lateral surface (37) causes the elastic pins (57) to open transversely, and the end portion (34) of the assembly shooter (30) can overcome the head (59) of the elastic pins (57), reaching the situation of Figures 1 1 and 12, in which the clipping surface (36) of the end portion (34) contacts a corresponding inner clipping surface (55) of the piston assembly (50) preventing the extraction of the end portion (34) of the piston assembly (50).
  • the pierceable sealing element (70) is arranged in a final position in which it prevents the passage of fluid through the inner cavity (53) of the piston assembly (50) and the longitudinal inner cavity (35) of the end portion (34) of the handle assembly (30), specifically the head (71) and part of the trunk (72) of the piston assembly arranged by closing the fluid passage. Furthermore, in this situation, as can be seen in Figure 1 1, the grip portion (32) of the handle assembly (30) remains accessible from outside the device (1).
  • the process of preparing the device (1) is continued by pulling the grip portion (32) of the handle assembly (30) backwards as indicated by the arrow (C), causing the handle assembly (30) to begin to retract along the inner cavity (15) of the tube (10) guided by the cover (90). Because the piston assembly (50) is clipped to the end portion (34) of the handle assembly (30), the piston assembly (50) and the pierceable sealing element (70) recede together with the handle assembly (30). The recoil of the piston assembly (50) causes a depression in the part of the inner cavity (15) of the tube (10) that is between the piston assembly (50) and the distal end (13) of the tube (10).
  • Figures 15 and 16 show two sectional views of the device (1) in the same situation as Figures 13 and 14, but the section having been made with a section plane that forms approximately 90 Q with the section plane corresponding to the Figures 13 and 14.
  • the helical channel (99) flows into the radial recess (97) where the clipping surface (98) is located.
  • the user continues to pull the grip portion (32) of the handle assembly (30) while rotating said grip portion (32) - and therefore the handle assembly ( 30) complete - clockwise.
  • the heads (59) of the elastic pins (57) penetrate the corresponding helical channels (99) of the cover (90), and there is a slight further recoil of the assembly formed by the handle assembly (30), the piston assembly (50) and the pierceable sealing element (70) at the same time as the rotation of said assembly with respect to the longitudinal axis (1 1) of the tube (10) as the heads (59) of the elastic pins (57 ) are ascending through respective helical channels (99). Because the space (15a) is under reduced pressure due to the recoil of the piston assembly (50), the pressure and tightness of the skirt (62) against the side wall (12) of the tube (10) is maintained.
  • a container or final tube which, analogously to a tube of conventional pre-filled vacuum, has an interior space (15a) with reduced pressure or vacuum conditions, and is permanently closed at one end (the distal end (13)) while the other end (the proximal end (14)) is closed by a perforable waterproof closure.
  • Said perforable seal is provided by the assembly formed by the cover (90), the piston assembly (50), the pierceable sealing element (70) and the end portion (34) -which remains clipped to the piston assembly (50) -.
  • the piston assembly (50) cannot move forward or backward along the tube (10) because it is clipped to the cover (90).
  • the vacuum conditions of the tube of the invention at the time of use are optimal
  • the vacuum conditions are generated at the time of its use, through the simple operation explained in the previous paragraphs.
  • the separable zone (33) of the handle assembly (30) may have a transverse dimension smaller than the end portion (34) of the handle assembly (30).
  • the separable zone (33) of the present embodiment is a notch or area of reduced diameter.
  • the longitudinal interior cavity (35) of the end portion (34) extends along the entire separable zone (33). This makes it possible to minimize the thickness of the walls of the separable zone (33) and ensure that the separable zone (33) is broken with relative ease.
  • the pierceable sealing element (70) of the present embodiment is disposed within the longitudinal interior cavity (35) of the end portion (34) of the handle assembly (30), and along the separable zone (33). This allows, although the walls of the separable zone (33) are thin, the effective thickness of the assembly formed by the handle assembly (30) and the pierceable sealing element (70) in the area of the separable zone (33) is increased and therefore the separable zone (33) does not break when the steps prior to breaking the handle assembly (30) (steps of Figures 7 to 18) are being performed.
  • Figure 20 further illustrates that the presence of the inner cavity (73) of the pierceable sealing element (70) makes it possible to minimize the thickness or height (h) of the layer of sealing material in the longitudinal direction and in the central area of the pierceable sealing element (70), while ensuring that the total height of the pierceable sealing element (70) is kept high to perform the reinforcing functions explained in the preceding paragraphs.
  • This facilitates the insertion of a needle through said central area when the device is used to collect blood or another compound.
  • the clipping surface (36) of the distal end (13) of the handle assembly (30) is arranged perimetrically and continuously around a central longitudinal axis of the end distal (13). This allows the handle assembly (30) to be clipped to the piston assembly (50) in any relative rotational position between them.
  • the elastic skirt (62) of the piston assembly (50) has an increasing width; for example, in the embodiment shown, the skirt (62) is conical. This allows the skirt (62) to fit tightly against the side wall (12) of the tube (10) regardless of whether the tube wall (10) is perfectly cylindrical or, on the contrary, has a slight taper or other slight variation of shape.
  • the skirt (62) has a wavy outer contour (63), which favors the tight fitting of the skirt against the side wall (12) of the tube (10).
  • This undulating shape has a lower stiffness when sliding inside the tube when the inner wall (12) has a conical surface. In this way the material of the piston assembly itself (50) looks less requested and can be less sophisticated.
  • Figures 21 to 24 show a second embodiment of a device (100) according to the invention, generally equal to the previous embodiment, including the fact that the device (100) comprises a pulling assembly (130) that includes a body elongate (131), a grip portion (132), a separable zone (133) and an extreme portion (134), where the latter has a longitudinal interior cavity (135) and at least one clipping surface (136).
  • a pulling assembly 130
  • body elongate a grip portion
  • 133 separable zone
  • 134 extreme portion
  • the latter has a longitudinal interior cavity (135) and at least one clipping surface (136).
  • the device (100) according to the invention differs from the embodiment of Figures 1 to 20 in that the grip portion (132) and the end portion (134) of the assembly Puller (130) are two separate pieces, and in which the separable zone (133) is a clipping or clipping detachable junction present between the grip portion (132) and the end portion (134).
  • Figures 21 and 22 show the device (100) in a situation analogous to the situation in Figure 17, that is, in which the handle assembly (130) has been pulled back and the handle assembly (130) turned clockwise, causing the piston assembly (50) to be clipped to the cover (90) in the same way as in the previous embodiment. Then, if the user exerts a sufficient tensile force on the grip portion (132) of the handle assembly (130), the situation of Figures 23 and 24 is reached, in which the clipped junction of the separable zone is unclipped. (133) and the grip portion (132) of the end portion (134) of the handle assembly (134) has been separated.
  • a container has been obtained that has a vacuum space (15a) delimited by a tube (12) closed by a lid (90) and a piston assembly (50) clipped to the lid (90), and said space being (15a) separated from the outside by a perforable element (70).
  • the tube can be used to draw blood, centrifuge blood, or other applications.
  • To access said space (15a) it is possible to insert a needle through the longitudinal inner cavity (135) of the end portion (134), the pierceable element (70) and the inner cavity (53) of the piston assembly (50) ), getting communication for the passage of a fluid through it.
  • Figures 25 and 26 show a third embodiment of a device (200) according to the invention.
  • the device (200) of the present embodiment has, like the previous embodiments, a tube (10), a cover (90) -not shown-, a piston assembly (250) provided with an inner cavity (253) of fluid passage, a pierceable sealing element (270) for tightly insulating a space (15a) inside the tube (10), and a handle assembly (30) accessible from the outside to move the piston assembly (250).
  • the handle assembly (30) of the present embodiment is constructed in one piece and with a separable zone (33) breakable;
  • the end portion (34) of the handle assembly (30) also has a longitudinal interior cavity (35).
  • the present device (200) differs from the previous embodiments in that the pierceable sealing element (270) forms part of the piston assembly (250), that is, at all times moves with the piston assembly (250).
  • the piston assembly (250) comprises an inner element (250a), which comprises the inner cavity (253) of the piston assembly (250).
  • the pierceable sealing element (270) is exterior, and comprises a transverse outer cover (270a) and an outer wall (270b) extending from the outer cover (270a) and surrounding a portion of the element interior (250a).
  • the outer cover (270a) has a through hole (270c) aligned with the inner cavity (253).
  • the inner element (250a) can be rigid to provide robustness to the piston assembly (250), while the elastic outer perforable sealing element (270) guarantees the tight contact against the wall (12) of the tube ( 10).
  • the inner element (250a) may be slightly smaller than the end portion (34) of the handle assembly (30), so that when the end portion (34) is clipped to the inner element (250a) it causes an elastic widening of the latter, which in turn pushes out the pierceable sealing element (270), increasing the tight contact against the wall (12) of the tube (10).
  • Figures 27 and 28 show a variant of the previous embodiment, in situations analogous to those of Figures 25 and 26. In the present embodiment of Figures 27 and 28, the outer cover (270a) has no hole.
  • the portion of the inner element (250a) of the piston assembly (250) that is surrounded by the outer wall (270b) of the pierceable sealing element (270) applies an elastic thrust against the outer wall (270b) of the sealing element ( 270).
  • said elastic thrust is exerted by elastic side pins (290), which are inserted into the deformable perforable sealing element (270), so that they tend elastically to open (push radially towards outside) and therefore to widen the pierceable sealing element (270) and thereby contribute to the tight contact between the outer wall (270b) of the sealing element (270) and the side wall (12) of the tube (10). That is, the elastic side pins (290) and the outer wall (270b) have a joint operation analogous to the collapsible elastic skirt (62) of the embodiments of Figures 1 to 24.
  • Figures 29 and 30 show an embodiment of a device (300) alternative to the previous ones.
  • the present device (300) comprises a handle assembly (330) and a piston assembly 8350) movable inside a tube (10).
  • the handle assembly (330) is provided with an elongated body (331), a grip or handle portion -not shown-, and a threaded end portion (334), that is, provided with an outer threaded profile (334a).
  • the end portion (334) has a longitudinal interior cavity (335), at least one surface of clipping (336), intended to be clipped to the piston assembly (350), and at least one side surface (337) oblique and of increasing width towards the clipping surface (336), which contributes to causing the clipping, similarly to modes of previous performance.
  • the clipping surface (336) and the lateral surface (337) of the present embodiment form part of the external threaded profile (334a).
  • the piston assembly (350) is formed by a first piece (351) provided with elastic pins (357) similar to those of previous embodiments; said elastic pins (357) comprise an inner clipping surface (355) and an outer clipping surface (361), intended to be clipated respectively with a clipping surface (336) and with the cap -not shown-, similar to previous embodiments.
  • the piston assembly (350) of the present embodiment has a skirt (362) of operation analogous to that of the skirt (62) of the first embodiment described herein.
  • the piston assembly (350) can be pushed along the tube (10) by the handle assembly (330) until it reaches the bottom of the tube (10). Then, if the pulling assembly (330) is continued to be pushed with sufficient force, the conical lateral surfaces (337) push and deform the elastic pins (357) and it is produced that the end portion (334) is inserted between the elastic pins (357 ), said end portion (334) being clipped by means of the contact and top between the clipping surfaces (336) and the inner clipping surfaces (355) of the elastic pins (357).
  • the disconnection of the handle assembly (300) from the piston assembly (350) occurs differently.
  • the puller assembly (330) and the piston assembly (350) are retracted until they are clipped to the plug (analogously to Figure 18)
  • the puller assembly (330) is unscrewed from the elastic pins (357) by rotating the handle assembly (330) with respect to the piston assembly (350), which is rotationally fixed in said direction of rotation because it abuts the stopper.
  • the present embodiment comprises a perforable sealing element (370) that is part of the piston assembly (350).
  • the rest of the piston assembly (350) can be made of one or more pieces (the example illustrated includes two) and one more materials of varying stiffness.
  • the tube of the present invention may be made of glass, plastic or any other applicable material, and may or may not be provided with a surface treatment.
  • the device may be presented completely or partially disassembled.
  • the device can be presented in situations analogous to that of Figure 1 1 (which coincides with Figure 1), that is, with the puller assembly and the piston assembly inserted to the bottom of the tube and the clipping having occurred between them, so that the user who is going to use the tube only has to unpack it, pull the handle assembly back, turn the handle assembly and separate (eg break or unclip) it to obtain a tube with an optimum vacuum ready To be used.
  • the device can be marketed with the empty tube (10), that is, without containing any additive (e.g., no coagulating substance, anticoagulant, etc.).
  • the tube (10) can be marketed with some additive.
  • the tube (10) may be marketed containing at least one procoagulant.
  • the tube (10) may have procoagulant surface properties derived from the manufacturing materials of the tube (10) or the geometry of its interior walls.
  • the tube (10) may be made of glass or may have a procoagulant coating such as glass, silicone, kaolinite, cerite, or bentonite.
  • the inner wall of the tube (10) may be treated with ionized gas to accelerate the coagulation of a blood plasma contained therein during the use of the tube (10).
  • the internal surface may have a roughness that allows the coagulation of said plasma to accelerate.
  • the procoagulant surface properties may be present on all or part of the surface of the inner walls of the tube (10).
  • the use of a procoagulant tube (10) makes it possible to accelerate the coagulation of a plasma contained in the tube (10) in those circumstances in which it may be convenient for the medical or surgical technique in which a final composition obtained from the plasma is to be used. .
  • the tube (10) may have anticoagulant surface properties derived from the manufacturing materials of the tube (10) or the geometry of its interior walls.
  • the tube (10) may be made of or coated with hydrophobic polymers such as polyethylene, polypropylene, polytetrafluoroethylene, polyvinylchloride, polyethylene terephthalate, polysiloxane, polystyrene, polycarbonate, cyclic olefin copolymer.
  • the inner surface of the tube (10) can be treated with ionized gas to produce hydrophobic properties.
  • an anticoagulant tube (10) makes it possible to delay the coagulation of blood or plasma contained in the tube (10) in those circumstances in which it may be convenient for the medical or surgical technique in which a composition prepared by the tube (10). Delaying blood clotting allows you to lengthen the waiting time before centrifuging the blood to obtain the plasma, if necessary.
  • Anticoagulant surface properties may be present in all or part of the surface of the inner walls of the tube (10), this aspect also influencing the degree of coagulation delay.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
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  • Hematology (AREA)
  • Pathology (AREA)
  • Physics & Mathematics (AREA)
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  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Manufacturing & Machinery (AREA)
  • Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Dermatology (AREA)
  • Pain & Pain Management (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Hydrology & Water Resources (AREA)
  • Biochemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
PCT/ES2016/070388 2015-06-03 2016-05-23 Dispositivo de recolección de sangre WO2016193513A1 (es)

Priority Applications (11)

Application Number Priority Date Filing Date Title
CN201680031851.XA CN107735028B (zh) 2015-06-03 2016-05-23 用于收集血液或血液复合物的装置
BR112017025837-4A BR112017025837B1 (pt) 2015-06-03 2016-05-23 Dispositivo para a coleta de sangue ou de um composto sanguíneo
ES16726353T ES2751678T3 (es) 2015-06-03 2016-05-23 Dispositivo de recolección de sangre
EP16726353.2A EP3305195B1 (en) 2015-06-03 2016-05-23 Blood collection device
JP2017562709A JP6737817B2 (ja) 2015-06-03 2016-05-23 血液の採取のための装置
KR1020177034501A KR20180014711A (ko) 2015-06-03 2016-05-23 혈액 수집 장치
RU2017141930A RU2694468C2 (ru) 2015-06-03 2016-05-23 Устройство для взятия крови или препарата крови
PL16726353T PL3305195T3 (pl) 2015-06-03 2016-05-23 Urządzenie do pobierania krwi
MX2017013467A MX361558B (es) 2015-06-03 2016-05-23 Dispositivo de recoleccion de sangre o de un compuesto sanguineo.
CA2988027A CA2988027C (en) 2015-06-03 2016-05-23 Device for the collecting of blood or a blood compound
CONC2017/0013373A CO2017013373A2 (es) 2015-06-03 2017-12-26 Dispositivo de recolección de sangre

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ESP201530776 2015-06-03
ES201530776A ES2593042B1 (es) 2015-06-03 2015-06-03 Dispositivo de recolección de sangre o de un compuesto sanguíneo

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JP (1) JP6737817B2 (zh)
KR (1) KR20180014711A (zh)
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AR (1) AR104885A1 (zh)
BR (1) BR112017025837B1 (zh)
CA (1) CA2988027C (zh)
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ES2675824B1 (es) * 2017-01-12 2019-04-29 Biotechnology Inst I Mas D Sl Dispositivo contenedor para la recoleccion, el almacenamiento y el procesado de sangre o de un compuesto sanguineo
BR112020000944A2 (pt) * 2017-07-17 2020-07-14 Becton, Dickinson And Company dispositivo para aprisionamento de um fluxo inicial de sangue
KR102025496B1 (ko) * 2017-09-05 2019-09-25 이준석 원심분리용 피스톤 및 이를 포함하는 원심분리 장치
IT201700117934A1 (it) * 2017-10-18 2019-04-18 Univ Degli Studi Di Verona Contenitore per l’esecuzione di procedure mediche o veterinarie e relativo metodo di calibrazione
US10391517B1 (en) * 2018-05-30 2019-08-27 Sulzer Mixpac Ag Dispenser assembly
CN112105406A (zh) * 2018-07-13 2020-12-18 株式会社汉卓德 取液注射针
CN109124654A (zh) * 2018-10-24 2019-01-04 山东亨洁医用包装科技有限公司 一种真空采血管
RU2740100C1 (ru) * 2020-06-19 2021-01-11 Сергей Анатольевич Демкин Вакуумная пробирка для получения обогащённой тромбоцитами аутологичной плазмы
CN112790773A (zh) * 2021-02-01 2021-05-14 徐州宏阳医疗科技有限公司 一种活塞式采血器

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BR112017025837B1 (pt) 2021-04-06
EP3305195B1 (en) 2019-07-10
TWI700108B (zh) 2020-08-01
CN107735028A (zh) 2018-02-23
AR104885A1 (es) 2017-08-23
ES2593042A1 (es) 2016-12-05
CA2988027C (en) 2021-01-26
EP3305195A1 (en) 2018-04-11
ES2751678T3 (es) 2020-04-01
US20160354020A1 (en) 2016-12-08
JP6737817B2 (ja) 2020-08-12
US10376194B2 (en) 2019-08-13
MX2017013467A (es) 2018-03-01
PT3305195T (pt) 2019-08-26
CO2017013373A2 (es) 2018-04-19
ES2593042B1 (es) 2017-10-03
CN107735028B (zh) 2020-12-29
PE20171771A1 (es) 2017-12-21
KR20180014711A (ko) 2018-02-09
BR112017025837A2 (pt) 2018-08-14
RU2017141930A3 (zh) 2019-07-17
PL3305195T3 (pl) 2019-11-29
RU2017141930A (ru) 2019-07-09
CA2988027A1 (en) 2016-12-08
JP2018521728A (ja) 2018-08-09
TW201701909A (zh) 2017-01-16
RU2694468C2 (ru) 2019-07-15
MX361558B (es) 2018-12-07
CL2017002975A1 (es) 2018-03-16

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